AccessGUDID - DEVICE: BR Surgical, LLC (00840183512484)

GUDID

Device Identifier (DI) Information

Brand Name: BR Surgical, LLC
Version or Model: BR50-17122
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BR50-17122
Company Name: BR Surgical, LLC

Primary DI Number: 00840183512484
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134781207 *Terms of Use

Device Description: FISHER Tonsil Knife and Dissector, 15mm curved blade with sharp edge at flat tip, top edge serrated, 9"

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
33452	Tonsil dissector, reusable	A hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used during the dissection of the tonsils during ear/nose/throat (ENT) surgery. It can be designed in several configurations, e.g., with a shaft that terminates at the distal end with a rounded, curved or angled tip, or it may be double-ended. The tip may be pointed, flat, sharp or blunt and angled or straight from the shaft and may or may not be serrated. It is made of high-grade stainless steel, available in various shapes and sizes, and may include suction capabilities. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KBM	Dissector, Tonsil

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 98c537e7-160e-42b5-91f3-d796773f574c
Public Version Date: June 18, 2024
Public Version Number: 1
DI Record Publish Date: June 10, 2024